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Leveraging proprietary technologies to address significant unmet medical needs.

Ironshore Pharmaceuticals & Development, Inc. has the following drug approved:


JORNAY PM (methylphenidate HCl Extended-Release CII Capsules) (formally HLD200)

Indication: JORNAY PM is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older

JORNAY PM is a novel formulation of methylphenidate leveraging the DELEXIS® technology. The first and only stimulant dosed in the evening, JORNAY PM has demonstrated improvement in ADHD symptoms when the patient awakens the next morning and throughout the rest of the day. JORNAY PM was approved by the US FDA in August 2018 and be will be commercially available in the US market in June 2019.

Click here for the Full Prescribing Information, including Boxed Warning, for JORNAY PM.


IMPORTANT SAFETY INFORMATION

JORNAY PM is a federally controlled substance (CII) because it contains methylphenidate, which can be a target for people who abuse prescription medicines or street drugs. Keep JORNAY PM in a safe place to prevent misuse and abuse. Selling or giving away JORNAY PM may harm others and is against the law. Tell your healthcare provider if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.

JORNAY PM should not be taken if you or your child is allergic to methylphenidate hydrochloride or any of the ingredients in JORNAY PM, or is taking or have taken within the past 14 days an antidepressant called a monoamine oxidase inhibitor (MAOI).

Heart-related problems have been reported with methylphenidate products and other stimulant medications:

  • Sudden death in children who have heart problems or heart defects
  • Sudden death, stroke and heart attack in adults
  • Increased blood pressure and heart rate
  • Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with JORNAY PM.

Your physician should check your or your child’s blood pressure and heart rate regularly during treatment with JORNAY PM.

JORNAY PM can cause serious side effects, including psychiatric disorders which have been reported with methylphenidate products and other stimulant medications:

  • New or worse behavior and thought problems
  • New or worse bipolar illness
  • New psychotic symptoms (such as hearing voices or seeing or believing things that are not real) or new manic symptoms. Tell your healthcare provider about any mental problems you or your child has or about a family history of suicide, bipolar illness, or depression.

Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon) have been reported with methylphenidate products and other stimulant medicines:

  • Fingers or toes may feel numb, cool, or painful
  • Fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

Call your physician right away if you or your child experiences any heart-related symptoms, such as chest pain, shortness of breath or fainting, new or worsening mental (psychiatric) symptoms or new manic symptoms, or signs of unexplained wounds appearing on fingers or toes while taking JORNAY PM.

JORNAY PM may not be right for you or your child. Before starting JORNAY PM, tell your or your child’s physicians about all health conditions (or a family history of) including:

  • Heart problems, heart defects, high blood pressure
  • Mental problems, including psychosis, mania, bipolar illness, or depression
  • Circulation problems in fingers and toes
  • If you are pregnant or plan to become pregnant. It is not known if JORNAY PM will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant
  • If you are breastfeeding or plan to breastfeed. JORNAY PM passes into your breast milk. You and your doctor should decide if you will take JORNAY PM or breastfeed

Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines (especially if you or your child takes medicine to treat depression, including MAOIs), vitamins, and herbal supplements.
Avoid drinking alcohol during treatment with JORNAY PM. This may cause a faster release of the JORNAY PM medicine.

Possible serious side effects of JORNAY PM are heart-related problems, psychiatric disorders, circulation problems in fingers and toes, and slowing of growth (height and weight) in children. Children should have their height and weight checked often while taking JORNAY PM. JORNAY PM treatment may be stopped if a problem is found during these checkups. Painful and prolonged erections (priapism) have occurred with methylphenidate hydrochloride. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a physician immediately.

The most common side effects of methylphenidate products in children, adolescents, and adults with ADHD include: decreased appetite, stomach pain, irritability, trouble sleeping, weight loss, mood swings (affect lability), nausea, anxiety, increased heart rate, vomiting, dizziness, increased blood pressure, and indigestion.

The most common side effects of JORNAY PM in children age 6 to 12 with ADHD include:

  • Trouble sleeping
  • Nausea
  • Decreased appetite
  • Mood swings
  • Restlessness (psychomotor hyperactivity)
  • Vomiting
  • Headache

These are not all the possible side effects of JORNAY PM.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Reference: 1. JORNAY PM [package insert]. Ironshore Pharmaceuticals & Development, Inc.; 2018.

IMPORTANT SAFETY INFORMATION

  • JORNAY PM is a federally controlled substance (CII) because it contains methylphenidate, which can be a target for people who abuse prescription medicines or street drugs. Keep JORNAY PM in a safe place to prevent misuse and abuse. See full prescribing information for complete boxed warning.
(Scroll down for additional Important Safety Information)